Universal Medical Device
Nomenclature System
WHO Informal Consultation on
Nomenclatures for Medical
Devices
Vivian Coates, Vice President, ECRI
Institute
23-24 March, 2011
Geneva, Switzerland
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©2009 ECRI Institute
About ECRI Institute
 42 year-old not-for-profit research institute
 WHO and PAHO Collaborating Center for health technology
management and patient safety
 More than 380 full time staff in 4 offices (Phila, KL, London, Dubai)
 Conduct applied research and provide consultancy on medical
devices, health technology assessment and patient safety
 Operate under very strict conflict of interest rules
 Produce 35 databases and publications
 Medical device education and training programs
 Developed/maintain Universal Medical Device Nomenclature
System (UMDNS) since 1971
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©2009 ECRI Institute
Sustainability and Management of UMDNS:
 ECRI’s obligation to maintain UMDNS is recognized by our
Board of Trustees
 Part of our WHO Collaborating Center Terms of Reference
 Used in all our medical device databases and information
products and services
 Continuously maintained and managed by dedicated technical
and clinical staff as a core activity of ECRI
 All other professional staff with medical device expertise
contribute to nomenclature review and development
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©2009 ECRI Institute
About UMDNS
 The 2011 UMDNS contains more than 26,000 medical device
terms

9,110 preferred terms

More than 17,000 entry terms

2,340 licensees in more than 100 countries (many more individual users)
ECRI’s UMDNS: Current Users
 2340 Licensees in 100 countries: actual number of individual hospital and
organizational end users much larger (e.g., 1 license to the Malaysian MOH
covers 150 hospitals)
 Regulatory agencies - post market surveillance, vigilance reporting, product
registration, data storage and retrieval
 Other govt.agencies (ministries of health, US DOD, VA, NLM)
 Private health systems, healthcare facilities, NGO’s: for inventory control,
hazard and recall tracking, equipment planning, procurement, technology
management, monitoring emerging technology, emergency preparedness (in
conjunction with ECRI’s data)
 IT software vendors of hospital equipment computerized maintenance
management systems
 Consulting firms and Websites for procurement and trade
Current Uses
 Manufacturers - classifying product line
to facilitate communication with hospitals
 Application developers utilizing UMLS
vocabularies
 WHO – embedded in iHTP software tool
for resource planning for populationbased care in developing countries
 eCommerce exchanges – linking ECRI
data used by hospitals to eCommerce
transactions (via UMDNS-to-UNSPSC
mappings)
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©2010 ECRI Institute
 Australian Patient Safety Foundation –
embedded in software system used for
coding adverse event reports/analyzing
medical errors from all Australian
hospitals (APSF system also used in UK
and other countries)
 New: Medical Device Control Office –
Department of Health, The Government of
the Hong Kong Special Administrative
Region for the Asian Medical Device
Nomenclature System [AMDNS]
ECRI’s Technical Approach to UMDNS:
 Formal, hierarchical system for organizing device-related
information
 Not simply a list of products: a database
 Dynamic: maintained and updated continuously to reflect
advances in medical technology (eg, in 2010, 558 preferred
terms added/modified, including 220 for medical software, 1847
new/modified entry terms)
 constant monitoring to maintain and improve quality
 Worldwide user feedback a critical input for UMDNS
 As both a user and nomenclature developer, ECRI understands
user perspectives and priorities
UMDNS Content:
Preferred terms and codes
Entry terms
Hierarchy
Parent-child as well as sibling relationships (Cross
references)
Attributes
Definitions
Mappings and linkages
UMDNS Scope:
 Covers all medical devices and supplies, clinical laboratory
equipment and reagents, selected hospital furniture, systems
and test equipment
 Since 2001, thousands of new terms developed by ECRI for
disposables, molecular diagnostic tests, emergency
preparedness, medical software and emerging technologies
 Related dataset includes 30,000 device
manufacturer/supplier/servicer company names and their
associated 6-digit codes
UMDNS Organization:
Unique 5-digit numeric code/identifier corresponding to
each preferred term
 Assigned randomly and sequentially
 Codes intentionally do not carry inherent meaning
Examples:
 18504 Defibrillator/Cardioverter/Pacemakers, Implantable
 20376 Defibrillator/Cardioverter/Pacemakers, Implantable,
Resynchronization
 17577 Testers, Implantable Defibrillator/Cardioverter
Entry Terms:
User-friendly entry points to UMDNS
Entry terms include synonyms, quasi-synonyms, lexical
variants, initialisms, or acronyms
Also may include imprecise and/or extremely broad or
extremely narrow/specific concepts not appropriate for
preferred terms
eg, Ophthalmic lasers, MRI units, Bovies, PRN
Adapters, Q-Tips
Concept Definitions:
Formal definition for each preferred term/coded concept
Constructed in a standardized way
Describe the device and its intended purpose
Help to prevent ambiguity, redundancy or overlapping of
concepts for similar devices
Concept Permanence
Concepts are never removed, but may become obsolete or
retired (their status changes)
Codes for retired concepts and terms are never re-used for
new concepts
In most cases, a retired preferred term becomes an entry
term pointing to the new preferred term or terms
Archival list of retired preferred terms is retained in the
master database
Attributes:
 Characteristics of particular UMDNS concepts
 Each preferred term may be linked to different attributes in the
UMDNS database
 eg, Implantable device, capital equipment, one or more clinical
specialties, price, FDA regulatory class, useful life, “used with”,
“part of” etc.
Hierarchical Structure of UMDNS:
Powerful tool for representing devices used in healthcare
Differentiates nomenclature from a flat dictionary or
glossary list
Multiple levels of categories broader than the level
represented by the preferred terms/device groups in
UMDNS
Definitions for uppermost levels inclusive of all devices
grouped under each level
UMDNS utilizes multi or polyhierarchy
Hierarchy at the uppermost level
 Healthcare Devices: Level 1





Main Equipment and Systems
Surgical Instruments/Kits/Sets/Ancillary Devices
Supplies
Prostheses/Implants/Orthoses/Grafts
IVD Reagents/Test Kits
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Hierarchy at next lowest level
 Prostheses/Implants/Orthoses/Grafts – Level 2





Prostheses & Trial Prostheses
Stents & Stent-Grafts
Implants
Grafts
Orthoses
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©2010 ECRI Institute
Hierarchy at Device Group/UMDNS Preferred Term level
 Active Implantable Devices
 Pacemakers and Defibrillators
― Defibrillator/Cardioverter/Pacemakers, Implantable
 Defibrillator/Cardioverter/Pacemakers, Implantable, Resynchronization
― Defibrillator/Cardioverters, Implantable
― Defibrillator/Pacemakers, Implantable
― Defibrillators, Implantable
 Pacemakers, Cardiac, Implantable
― Pacemakers, Cardiac, Implantable, Resynchronization
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©2010 ECRI Institute
Hierarchy at Device Group/UMDNS Preferred Term level
 Active Implantable Devices
 Leads
―
―
―
―
―
―
―
Leads Implantable Defibrillator
Leads Implantable Defibrillator/Pacemaker
– Leads, Implantable Defibrillator/Pacemaker, Resynchronization
Leads, Pacemaker
– Leads, Pacemaker, Implantable
» Leads, Pacemaker, Implantable, Endocardial
» Leads, Pacemaker, Implantable, Myocardial
– Leads, Pacemaker, Temporary
» Leads, Pacemaker, Temporary, Endocardial
» Leads, Pacemaker, Temporary, Myocardial
Leads, Electrical Stimulator
Leads, Pacemaker, Transesophageal
Leads, Spinal Cord, Implantable
Pacemaker Lead Adaptors, Implantable
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©2010 ECRI Institute
UMDNS Licensing and Distribution:
 Licensed from ECRI (basic version free of charge to government agencies,
individual hospitals, manufacturers, fees for eCommerce sites and commercial
software companies; fees for additional data, special formats, other IT
services)
 Free version available electronically as an ASCII or Excel download from
UMDNS Web page, updated monthly
 User support by fax, email, telephone
 Special arrangements for supporting translation efforts
UMDNS Licensing and Distribution:
 Commercial license fee based on level of support and data (eg, Web services,
specialized formats, monthly updates, usually with data on suppliers and their
product lines)
 Commercial licensees do not pay a per-user fee, but per institution (for unlimited
use within the institution)
 eg, application developer loads UMDNS into the software application
Questions?
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©2009 ECRI Institute